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Presentation of Young Adults With and Without Joint Hypermobility

2026年6月17日 更新者:Leslie Russek、Clarkson University

Prospective Study of Symptoms in People With and Without Joint Hypermobility

People with multiple hypermobile joints are diagnosed with Generalized Joint Hypermobility (GJH) when asymptomatic, or Hypermobile Ehlers-Danlos Syndrome (hEDS) and Hypermobility Spectrum Disorder (HSD) when symptomatic (hEDS/HSD, or 'HSD' here). GJH likely affects about 20% of the U.S. population, while HSD affects 0.5-3% of the US population. Although joint hypermobility is the most visible presentation of HSD, it is a systemic connective tissue disorder affecting multiple body systems. Due to frequent health concerns, HSD may contribute to more than 30% of patients in chronic pain, rheumatology, orthopedic and physical therapy clinics. It is still unclear why some people have asymptomatic hypermobility and others develop complex chronic health issues. However, recent research suggests that the transition might be triggered by severe physiological stress, such as viral infection.

HSD is commonly associated with Postural Orthostatic Tachycardia Syndrome (POTS) and Mast Cell Activation Syndrome (MCAS), as well as gastrointestinal (GI) problems. Recent research suggests that persistent inflammation due to MCAS or COVID may trigger HSD symptoms. The correlation between POTS and HSD may be due to effects of HSD on the autonomic nervous system or to inflammation triggering both conditions. It is also unclear whether body awareness and coordination deficits seen in symptomatic HSD are due to the fundamental connective tissue disorder or due to pain and injuries in HSD. This study seeks to determine whether asymptomatic hypermobile individuals (GJH) also have balance and coordination deficits. The current study hopes to identify factors that correlate with a transition from asymptomatic GJH to symptomatic HSD by following a group of Health Science students forward in time. The study will collect baseline health information including relevant diagnoses, symptoms and function. Physical measurements will include standard clinical tests performed by physical therapists: joint hypermobility and instability, standing balance, neck movement control, and heart rate in response to standing from lying down. The study is likely to last for at least 10 years to follow participants over time.

研究概览

详细说明

Most hyper mobility-related research is conducted by clinical researchers, who are generally limited to recruiting research subjects from patients who present to their clinics. There are few opportunities for longitudinal studies of asymptomatic or 'healthy' individuals to identify potential triggers prospectively and to compare to people who do not develop symptoms. A health care academic institution provides the ideal environment for a prospective study, somewhat like the 'Nurses Health Study'* that followed a population of nurses throughout their lives.

The study will collect initial data on:

  • Current diagnoses related to HSD, MCAS, and POTS (questionnaire)
  • Current symptoms associated with HSD, MCAS and POTS (questionnaire)
  • Overall quality of life (questionnaire)
  • Physical measures for diagnosing joint hypermobility and instability
  • Physical screening for POTS
  • Physical screening for body awareness, balance and coordination

Objectives and Hypotheses

  1. What is the prevalence of HSD, POTS and MCAS in a 'healthy' young adult population?
  2. How often are HSD, POTS and MCAS undiagnosed in a 'healthy' young adult population?
  3. Are there factors that trigger or precede the development of widespread symptoms in people who have GJH, causing them to develop HSD?
  4. What risk factors are associated with increased likelihood that an individual will develop POTS, MCAS, or HSD?
  5. Do balance or motor control in the neck differ in asymptomatic joint hypermobility compared to symptomatic hypermobility?
  6. If coordination impairments exist in asymptomatic people with hypermobility, does that predict development of HSD?

Questionnaires will be on secure Google Forms accessed through participants' phones or other electronic devices. Participants may pause and return to the questionnaires if they choose. We intend for the questionnaires to require no more than 30 minutes to complete; we may need to eliminate questions from the current list to achieve this.

Physical measurements will be performed only at the initial data collection. These measurements will be performed by licensed physical therapists, who may be assisted by physical therapy graduate students with adequate training to assist in selected data collection. Data collection will take place in Clarkson Hall. Measurements are likely to be performed at 'stations' by various assessors, but any participant who would like to be in a private room for any or all of the assessment may request that. Physical measurements are likely to take about 30 minutes.

Each year, we will follow up by emailing participants asking them to complete questionnaires that will be a subset of the initial set of questions. Questionnaires will again be implemented through secure Google Forms.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • New York
      • Potsdam、New York、美国、13699
        • Clarkson University, Lewis School of Health & Life Sciences
        • 接触:
        • 接触:
        • 首席研究员:
          • Leslie Russek, PT, DPT, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Health Science graduate students are typically 20-35 years old, though some non-traditional students might be slightly older.

描述

Inclusion Criteria: Clarkson University Health Sciences students. -

Exclusion Criteria: Other physical conditions that preclude collecting >25% of physical measurements at initial data collection.

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
hypermobile - symptomatic
People who meet the diagnostic criteria for hEDS or HSD
non-hypermobile
People who do not meet the diagnostic criteria for generalized joint laxity, hEDS or HSD
hypermobile - non-symptomatic
People with generalized joint laxity but not meeting diagnostic criteria for hEDS/HSD

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Hypermobility status
大体时间:5 years
Subject meets diagnostic criteria for generalized joint hypermobility, hypermobile Ehlers-Danlos Syndrome or Hypermobility Spectrum Disorders. This will be nominal: None, GJH, HSD hEDS.
5 years

次要结果测量

结果测量
措施说明
大体时间
EuroQol, 5-Dimension, 5-Level (EQ-5D-5L)
大体时间:5 years
5-domain quality of life measure: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It scores each domain on a 1-5 scale, where higher scores indicate greater disability. The scores are not summed.
5 years
Hypermobility Spider Questionnaire
大体时间:5 years
31-item questionnaire quantifying symptoms in 8 domains: Neuromusculoskeletal, Pain, Fatigue, Gastrointestinal, Cardiac Dysautonomia, Urogenital, Anxiety, Depression. Each domain is scored 0-100, where 0 is no symptoms in that domain, and 100 is the most symptoms in that domain.
5 years

其他结果措施

结果测量
措施说明
大体时间
New comorbidities
大体时间:5 years
New presentation of POTS or MCAS
5 years
Physical activity
大体时间:5 years
Modified International Physical Activity Questionnaire short form measures vigorous, moderate, and light exercises and computes 'metabolic minutes' or METs. Minimum score of 0 indicates no exercise. The maximum possible score allowed is 19,278.
5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月20日

初级完成 (估计的)

2036年6月20日

研究完成 (估计的)

2036年6月20日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

To ensure privacy of health information in a fairly small subject pool.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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